A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
Completed · Not applicable
Conditions studied: n Ulcer, Scleroderma, Systemic
In brief
This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.
Key facts
- Study ID
- NCT00725361
- Run by
- Stanford University
- People needed
- 20
- Starts
- 2008-06-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2017-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of limited or diffuse systemic sclerosis (SSc) according to American College of Rheumatology or LeRoy criteria
- Age greater than 18 years of age
- At least one digital ulcer located on the volar or lateral surface at or distal to the proximal interphalangeal joints
- At least one new DU that developed within 12 weeks prior to screening
- Vasodilator therapies, including calcium channel blockers, alpha-1-antagonists, ACE-inhibitors, nitroglycerin, and angiotensin receptor blockers, are permitted as long as the doses are stable for 2 weeks prior to screening and throughout the study
- Treatment with omeprazole or other proton pump inhibitors must be stable for 2 weeks prior to screening and throughout the study
You may not qualify if…
- Patients with pulmonary arterial hypertension, NYHA Class III or IV
- Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary failure
- Concurrent malignancy except non-melanoma skin cancers
- Patients who have required systemic antibiotics for infected digital ulcers within 2 weeks of screening
- Patients receiving phosphodiesterase-5 inhibitors, endothelin receptor antagonists, or prostanoids within 4 weeks of screening
- Patients receiving cyclosporine within 6 weeks of screening
- Patients who have participated in any investigational study within 30 days of screening
- Pregnant or nursing women
- Patients with a history of drug or alcohol abuse within 6 months of screening
- History of hepatitis B, hepatitis C, or HIV infection
- Any medical condition that, in the opinion of the investigator, might interfere with the subject's participation in the study or poses an added risk for the subject
- Inability to comply with study and follow-up procedures
- Transaminase elevation > 3X the upper limit of normal at screening
- Hemoglobin less than 8.5 g/dL
- Platelet count less than 100 X 109/L
- White blood cell count less than 3.0 X 109/L
- Serum creatinine less than 2.0 mg/dL
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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